WHO identify key bacteria for which new antibiotics are urgently needed

The WHO have published its first ever list of antibiotic-resistant “priority pathogens” – a catalogue of 12 families of bacteria that pose the greatest threat to human health. Dr Marie-Paule Kieny, WHO’s Assistant Director-General for Health Systems and Innovation said “Antibiotic resistance is growing, and we are fast running out of treatment options”. The list is intended to spur governments to put in place policies that incentivize basic science and advanced R&D by both publicly funded agencies and the private sector investing in new antibiotic discovery. G20 health experts will meet this week in Berlin, where the fight against antibiotic resistance will be discussed. Destiny Pharma commented, “Identification of priority target bacteria is important to allow focus on new drug developments to tackle them. Destiny Pharma’s platform technology, the XF Drug series have already been shown to be active against 9 of the 12 bacterial species indicating that this new drug approach has the potential to deliver products against the highest priority infectious diseases.”

Destiny Pharma to present at the 18th BioEquity Europe Meeting, Paris, France

Destiny Pharma today announced that they will be presenting at the BioEquity Europe 2017 meeting, to be held between the 22-23rd May in Paris, France. If you are attending the conference and would like to book an appointment to meet with us, please email us on busdev@destinypharma.com.

 

For more information on the meeting, please visit the BioEquity Europe page

21st Century Cures Act signed into law by President Obama

Destiny Pharma welcomes the enactment of the US 21st Century Cures Act. The provisions of the act underline the commitment of all those involved in the furtherance of policies to assist the development of novel medicines and to the removal of obstacles. Destiny is particularly pleased to see the retention of many of the specific policies to gather data on antimicrobial resistance patterns, to support antimicrobial stewardship and to provide practical drug approval pathways for tackling the most important microbial pathogens.

The Limited Population Pathway provides a route to the approval of antimicrobial products geared towards the most serious life threatening infections in difficult to study patient populations.  Allowing the use of very limited patient numbers in exchange for restrictive labelling and controlled marketing of the products. This measure seeks to address the issue of unavailability of highly restricted and difficult to find patients and seeks to drive the antimicrobial drug approval process for the most serious infections.

Destiny Pharma CEO appointed to the board of GAMRIF

Dr Bill Love, CEO of Destiny Pharma, has been appointed to the expert advisory board set up by the UK government to support the Global Antimicrobial Resistance Innovation Fund (GAMRIF). Professor Dame Sally Davies, the Chief Medical Officer for England, has appointed a 12-member multi-disciplinary board who will advise how the UK can best spend an additional £50 million over the next 5 years to work with global partners to fund innovative initiatives to tackle drug resistant infections, which includes resistance to antibiotics

Wellcome Trust report on boosting development of new antimicrobial drugs

Today, the Wellcome Trust have published a report entitled “Clinical Trial Networks for Antibiotic Development: Why they’re important and how they should be developed” which is the result of work undertaken by a multi-stakeholder working group, including Destiny Pharma’s Ian Hayter, which investigated the benefits of producing a clinical trial network to boost the search for new antibiotics. The report identifies that establishing such a network could result in up to a 23% saving on clinical trial running costs and a total saving of 40 – 60% of the total cost of trials could be achieved by also using a master trial protocol and allowing multiple trials to share a single control group.

Ian Hayter, Project Director at Destiny Pharma commented “I am very encouraged by this report, which identifies potential ways to reduce the cost and time for clinical trials for new antibiotics which would boost the development of new antibacterial drugs, which are urgently needed to combat the threat of multidrug resistant bacteria.”

 

Destiny Pharma to attend IDWeek in New Orleans, Louisiana

Destiny Pharma will be attending IDWeek which is being held in New Orleans, Louisiana between 26-30th October. IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA) the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).  Please contact us on conferences@destinypharma.com  if you would like to arrange a meeting during IDWeek. Please note that we have slots remaining only on the 26th October.

Momentous Step taken by UN to Fight Antibiotic Resistance welcomed by Destiny Pharma

Brighton, UK, 21 September 2016 – Destiny Pharma Ltd welcomes today’s United Nation’s meeting in New York where all 193 nations of the UN will sign a landmark declaration to pledge to rid the world of Antibiotic Resistant infections. This is only the fourth time the UN has focused on addressing a global healthcare issue in its history, underlining the worldwide concern on the impact that Antibiotic Resistance will have if left unchecked.

Among a number of actions that the UN will commit to is to encourage innovation for new antibiotics and novel antibacterial drugs, and to address the imbalance in the value of antibiotics to public health and society.

“This is a landmark announcement”, commented Dr Bill Love, CEO, Destiny Pharma, “It signals that the world is now serious about taking significant measures to reverse and address the healthcare crisis caused by antibiotic resistant bacteria. We expect that these positive developments will assist companies such as ours to deliver a pipeline of new and much needed novel antibacterial drugs.”

The United Nations, World Health Organization, Food and Agriculture Organization, and the OIE-World Organisation for Animal Health will provide a report containing a wide range of recommendations for action to address Antibiotic Resistance. The report will be delivered at the 73rd UN General Assembly in 2 years’ time.

For further information please contact:

Hume Brophy

Mary Clark, Eva Haas, Hollie Vile

Tel: +44 20 3440 5813

Email: destinypharma@humebrophy.com

About Destiny Pharma:

Destiny Pharma, a clinical stage biopharmaceutical company, was founded in 1997. The Company focuses on the R&D of new antimicrobial drugs, with an emphasis on novel mechanisms of action that seek to address the global healthcare issue, namely, Antibiotic Resistance. XF-73 is the Company’s lead drug which has completed 5 Phase I/IIa clinical studies in Europe/US. Through its extensive business network and strategic partnerships, Destiny Pharma intends to globally commercialize candidates from the XF Drug platform based on dicationic porphyrins which are differentiated from traditional antibiotics structurally. XF drug candidates are able to kill static and growing bacterial cultures, as well as bacteria with biofilm and may thus see limited resistance development. Non-growing cultures often become resistant to traditional antibiotics that rely on the bacteria actively growing to kill them. Additional information on Destiny Pharma is available at www.destinypharma.com

Press Release: Novel Antibacterial Drug, exeporfinium chloride, Delivers Encouraging Safety, Tolerability and Efficacy Data in US Clinical Trial

Brighton, UK, 5 September 2016 – Destiny Pharma Ltd, a leading clinical stage biopharmaceutical company focused on developing antibacterial medicines, today announced the results of a US clinical trial of the novel preventive anti-bacterial drug exeporfinium chloride (XF-73). The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, and was conducted at the NIAID Clinical Trials Unit at Case Western Reserve University in Cleveland and at Anaheim Clinical Trials in California.

The two-stage clinical trial studied the safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels. Part 1 yielded safety data in eight volunteers and allowed progression to Part 2 in 48 healthy volunteers with colonised nasal Staphylococcus aureus (SA) bacteria. Part 2 was double-blinded, placebo controlled, and investigated two exeporfinium chloride concentration gels (0.5 & 2.0mg/g) and two viscosities (2 and 4 percent) applied into the nostrils for 5 days.

Both concentrations were deemed safe and well-tolerated, and no drug was detected in the bloodstream. There was a similar safety profile observed in exeporfinium chloride and placebo-treated subjects, which is important because the product will be used in a preventive manner. In general, exeporfinium chloride demonstrated a rapid, anti-staphylococcal effect after 1 day, with the 2.0mg/g gel showing a statistical difference against placebo, which was sustained throughout dosing.

About 1 in 3 people carry SA in their nose, which increases the risk of a post-surgical SA infection by up to 10 times1,2. Using antibiotics to treat nasal SA carriage has been long practiced, but emergence of antibiotic resistant strains threatens the efficacy of the practice.3. In October 2015, the US Food & Drug Administration (FDA) recognised exeporfinium chloride as a Qualifying Infectious Disease Product (QIDP), and confirmed a new medical indication for the drug, namely for the “Prevention of Post-Surgical Staphylococcal Infections”.’4

Hospital-acquired SA infection remains a major concern, particularly the methicillin resistant SA (MRSA). Infection prevention measures, including treatment of SA/MRSA ahead of surgery in at-risk patients, are now practiced in many countries.

Still, there is an urgent global need for drugs that prevent SA infections but do not generate bacterial drug resistance. In the United States it is estimated that drug-resistant forms of SA such as MRSA result in 19,000 deaths per year5. The annual estimated cost of SA infection in the US is $14.5 billion6.

A report in The Lancet Infection Diseases in December 20157 estimates that between 38 and 51 percent of bacteria that cause post-surgical infections are resistant to traditional antibiotics. The report also estimates that a 30-percent reduction in antibiotic effectiveness could result in 120,000 additional post-surgical and chemotherapy-related infections in the US.

Compared to antibiotics, exeporfinium chloride has a novel structure and mechanism of action, killing SA bacteria rapidly without appearing to generate resistance8. These features make it an ideal candidate for the prevention of post-surgical SA infection.

Dr Bill Love, CEO of Destiny Pharma commented:We are delighted with these results, which demonstrate that exeporfinium chloride is safe and well tolerated and has the potential to deliver the FDA/QIDP awarded US indication for the prevention post-surgical SA infection. The support from NIAID made this study possible and we plan to progress this important new drug into the next stage of development and thereon to market.”

For further information please contact:

Hume Brophy

Mary Clark, Eva Haas, Hollie Vile

Tel: +44 20 3440 5813

Email: destinypharma@humebrophy.com

About the NIH and NIAID:

The US clinical trial was performed under DMID contract number HHSN27220800026C.

NIH, the U.S. medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research-at NIH, within the U.S. and worldwide-to study the causes of infections and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these illnesses.

News releases, fact sheets and other NIAID-related materials are available on the NIAID website at http://www.niaid.nih.gov/.

About Destiny Pharma:

Destiny Pharma, a leading, clinical stage biopharmaceutical company, founded in 1997. The Company focuses on the R&D of new antimicrobial drugs, with an emphasis on novel mechanisms of action that seek to address the global healthcare issue, namely, Antibiotic Resistance. Exeporfinium chloride is the Company’s lead drug which has completed 3 Phase I/IIa clinical studies in the UK/Europe. Through its extensive business network and strategic partnerships, Destiny Pharma intends to globally commercialise candidates from the XF Drug platform based on dicationic porphyrins which are differentiated from traditional antibiotics structurally. XF drug candidates are able to kill static and growing bacterial cultures, as well as bacteria with biofilm and may thus see limited resistance development. Non-growing cultures often become resistant to traditional antibiotics that rely on the bacteria actively growing to kill them. Additional information on Destiny Pharma is available at www.destinypharma.com

References:

  1. Wertheim HFL et al. The role of nasal carriage in Staphylococcus aureus infection. Lancet Infectious Diseases (2005); 5: 751-62
  2. Perl T et al. New approaches to reduce Staphylococcus aureus nosocomial infection rates: treating S. aureus nasal carriage. Annals of Pharmacotherapy (1998); 32(S): S7-16
  3. Sciortino CV et al. Surveillance of methicillin-resistant Staphylococcus aureus mupirocin resistance in a Veterans Affairs hospital. Infection Control & Hospital Epidemiology (2015); 36(2): 235-6
  4. Destiny Pharma Press Release dated 11 November 2015. Destiny Pharma Announces Qualified Infectious Disease Product Designation Granted by US FDA for Novel Antibacterial Product In Development for Prevention of Post-Surgical Staphyloccocal Infections.
  5. Klevens RM et al. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA (2007); 298(13): 1763-71
  6. Suaya JA et al. Incidence and cost of hospitalizations associated with Staphylococcus aureus skin and soft tissue infections in the United States from 2001 through 2009. BMC infectious diseases (2014); 14: 296
  7. Teillant A et al. Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modelling study. Lancet Infectious Diseases (2015); 298(15): 1429-37
  8. Farrell D et al. Investigation of the Potential for Mutational Resistance to XF-73, Retapamulin, Mupirocin, Fusidic Acid, Daptomycin, and Vancomycin in Methicillin-Resistant Staphylococcus aureus Isolates during a 55-Passage Study. Antimicrobial Agents and Chemotherapy (2011); 55(3): 1177-81

Forward Looking Statement:

This press release contains forward-looking statements that are subject to risks and uncertainties and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Destiny Pharma disclaims any intent or obligation to update forward-looking statements except as required by law.

Destiny Pharma invited to present at the inaugural Superbugs & Superdrugs USA Conference & Exhibition on the 14th and 15th November 2016 in New Jersey, USA

Destiny Pharma has been invited to present at the inaugural Superbugs & Superdrugs USA Conference & Exhibition on the 14th and 15th November 2016 in New Jersey, USA. The conference will include international speakers on the hot topics – superbug/superdrug defence strategy, funding opportunities, updates on R&D projects and look to define a risk mitigation plan to prevent global superbug outbreaks. Please contact us on conferences@destinypharma.com if you would like to arrange a meeting during Superbugs & Superdrugs USA.